BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT MEDIAL BLADE 23MM X 60MM

    MDR report key: 3082406 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11173
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    September 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT DEVELOPMENT EVALUATION SHOWED BLADE TOOTH FRACTURED DURING STERILIZATION. PERHAPS ANOTHER INSTRUMENT WAS PLACED ON TOP OF THE BLADE IN SUCH A WAY THAT THE STRESS CAUSED IT TO FRACTURE. BASED ON THE NUMBER OF RADIOLUCENT BLADES SOLD BETWEEN SEPTEMBER 2010 AND SEPTEMBER 2012, THE OCCURRENCE RATE OF THE TEETH FRACTURING DURING STERILIZATION IS APPROXIMATELY 3.571 PERCENT. HOWEVER, AS THESE BLADES ARE MEANT TO BE USED MULTIPLE TIMES DURING CERVICAL PROCEDURES, THE OCCURRENCE RATE SHOULD BE SIGNIFICANTLY LOWER. THIS COMPLAINT IS DEEMED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE MANUFACTURE DATE 04/12/2001. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RADIOLUCENT MEDIAL BLADE IS MISSING ONE OF THE TEETH ON THE BLADE. NOTHING BROKE DURING A PROCEDURE, BUT BROKE DURING WASHING. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185216 RADIOLUCENT MEDIAL BLADE 23MM X 60MM GAD SYNTHES GMBH AW10372

    Patients

    Seq Age Sex Outcome Treatment
    1